This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The Clinical Research Center provides administrative, nursing, and ancillary support for IRB approved clinical studies. The Center itself does not perform human research. The Center also supports research on secondary databases open to the public domain. DESCRIPTION (Adapted from the applicant''s abstract): Continued support is requested through the RCMI Clinical Research Infrastructure initiative for the RCMI-CRC. Specifically, continued support isrequested for the an increase in the nursing and dietary staffing, aclinically trained epidemiologist/biostatistician and expansion of the HAC. The original funded application for the RCMI-CRC at Drew was the first crucial step toward expanding patient care oriented research opportunities at the institution. Historically, RCMI-CRCs have played an influential role in medical advances, thereby setting standards for the practice of medicine and the quality of health care. The presence of a RCMI-CRC at Drew has led to an increase in the number of clinical research faculty and projects dedicated to the investigation of health issues that disproportionately affect minorities and disadvantaged populations. In addition, the presence of an RCMI-CRC has led to an increase in collaborative clinical research activities between Drewand the UCLA School of Medicine, Harbor/UCLA, USC, MCW, Mount Sinai Medical Center, N.Y., JHU, and Duke. During the initial four years of RCMI support, patient care oriented research activities have increased at Drew from eight to twelve;Public Health Service (PHS);i.e. National Institutes of Health (NIH), Centers for Disease Control(CDC)-funded clinical research studies (50 percent increase). An additional five projects have recently been funded as well as another three PHS applications under review. These projects represent an extraordinary opportunity for Drew. Unfortunately, without additional support, the RCMI-CRC is unable to handle the increased demand. In response to this institutional growth, increased funding is essentia lto expand RCRII- CRC capacity. As such, the broad objective of this renewal application is to expand the breadth of clinical research activities and sustain an increasing number of active clinical research faculty. The Hormone Assay Core Lab was established in 1996 under the auspices of the RCMI Clinical Research Center Infrastructure Initiative to expand the hormone assay capabilities at the Charles R. Drew University of Medicine and Science, by developing and making available hormone measurement methods that were not available to the investigators at that time. Since its inception 3 years ago, the Hormone Assay Laboratory has not only achieved all of its original goals, but has surpassed them in the area of new assay development and assay refinement In the next grant period the Core Laboratory will achieve the following objectives: 1) Continue to provide hormone assay capability at Drew University by not only performing some specialized assays, but by also providing facilities for orderly storage and distribution of blood samples from clinical research studies 2)Existing assays and develop new assays for the measurements of hormones and analytes will be improved by adapting and developing novel technologies for high throughput assays for rapid turnaround formore commonly used hormone measurements. New assays have been developed a) Measurement of Free Testoterone in Women by using a Highly Sensitive Equilibrium Dialysis Assay, b) Myostatin Radioimmunoassay. In the next funding period, we plan to provide the following assays to our users: a) Insulin, b) C-peptide, c)IGF-1,d)IGFBP-3, and e) C reactive protein.
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